Laser Fiber Assy-Single Use-LFS-200-0.22NA-SMA905-Extension Sleeve Silver-Sterile ETO-ForTec Fiber SU-200-TRUE-RT Label Smartscope packaging. The Laser peripherals bare laser fibers, ENT fibers and Endoprobes are intended for use in laser surgical procedure for cutting, coagulating, or vaporizing in
Check against the official notice below — it lists the full affected range.
Leoni Fiber Optics GmbH is recalling Laser Fiber Assy-Single Use products (model LFS-200-0.22NA-SMA905-Extension Sleeve Silver-Sterile ETO-ForTec Fiber SU-200-TRUE-RT) in Smartscope single-box packaging distributed to Ohio. Some packages may have broken seals that compromise sterility, and two reports of compromised sterility have been received. All products in this packaging are considered at risk.
Broken package seals could increase the risk of infection if the products are used. The affected lot/code is 096975 00816901020326. The source document does not specify what affected consumers should do regarding this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
A percentage of the products shipped in Smartscope single-box packaging may exhibit a broken package seal, thus having compromised sterility. There have been two reports of compromised sterility; however, all products packaged in Smartscope single-box packaging are at risk of a compromised product seal. Broken seal pouches compromise sterility and could increase the risk of infection if used.
Reason for recall: A percentage of the products shipped in Smartscope single-box packaging may exhibit a broken package seal, thus having compromised sterility. There have been two reports of compromised sterility; however, all products packaged in Smartscope single-box packaging are at risk of a compromised product seal. Broken seal pouches compromise sterility and could increase the risk of infection if used. Distribution: US Distribution to the state of: Ohio. Quantity: N/A Lot/code info: 096975 00816901020326
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.